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临床试验/NCT00951964
NCT00951964已完成2 期

Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

Centre Hospitalier Universitaire de Nice5 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
18
试验地点
5
主要终点
decrease of number of cutaneous bullosa

研究概览

简要总结

Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of cutaneous bullous lesion arising spontaneously or after mechanical trauma.

These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no treatment available. Cares are consisting to dress lesions and to protect the skin.

The investigators have recently observed on patients having residual expression of collagen VII that phenotype severity is modulated by activation degree of dermic metalloproteinase. The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be regulated this activity.

The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease the number of cutaneous bullosa after four month of treatment.

The primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa.

Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the average duration of cicatrisation and treatment tolerance.

This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.

When patients are included, they will be randomized and receive the treatment (or placebo) for 4 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • known mutation of COL7A1

排除标准

  • tea drinkers
  • patient receiving induction treatment,protease inhibitor treatment
  • liver failure

研究组 & 干预措施

1

Other

patients receive the treatment in first and placebo in second part of study

干预措施: Polyphenon E before Placebo (Drug)

2

Other

patients receive placebo in first and treatment in second part of study

干预措施: placebo before treatment (Drug)

结局指标

主要结局

decrease of number of cutaneous bullosa

时间窗: after 4 months of treatment

次要结局

  • efficacity of treatment(at 4 , 6, 7 10 months after beginnig of treatment and at year 1)
  • tolerance tio treatment(at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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